Enforcement record

承認 disclosure naming ロシュ・ダイアグノスティックス株式会社

ロシュ・ダイアグノスティックス株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure24 August 2022

Action type

承認

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

24 August 2022

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

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For developers: JSON integration details

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Action summary

Company
ロシュ・ダイアグノスティックス株式会社Japanese only
Original: ロシュ・ダイアグノスティックス株式会社
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
医薬品医療機器等法
Action type
承認
承認
Action date
24 August 2022
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医薬品・医療機器

Violation

Machine-translated summary — verify against original

Roche Diagnostics Corporation received approval for an over-the-counter COVID-19 antigen qualitative test kit on August 24, 2022, based on the Pharmaceuticals and Medical Devices Act, Article 23-2-5, Paragraph 1, as an in vitro diagnostic medical device.

Show original Japanese text

医薬品医療機器等法第23条の2の5第1項に基づき、体外診断用医薬品として承認を行った。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack
Extracted at
2026-05-05T00:01:15.844+00:00
Evidence checked
2026-05-05T00:01:15.844+00:00
Archive captured
2026-05-05T00:01:25.978984+00:00
Show audit JSON
{
  "record": {
    "id": "9bc593c5-dd56-4b41-9d9e-5c31e4a05cdc",
    "url": "https://regbase.jp/en/enforcement/other-rosiyudaiagunosuteitukusu-20220824",
    "company_name_original": "ロシュ・ダイアグノスティックス株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "承認",
      "en": "承認"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (ロシュ・ダイアグノスティックス株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-rosiyudaiagunosuteitukusu-20220824",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_27545.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/ce22b9ec52rv51nq",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_27545.html",
    "archiveCapturedAt": "2026-05-05T00:01:25.978984+00:00",
    "extractedAt": "2026-05-05T00:01:15.844+00:00",
    "translatedAt": "2026-07-06T07:41:43.375+00:00",
    "evidenceCheckedAt": "2026-05-05T00:01:15.844+00:00",
    "generatedAt": "2026-08-18T22:08:31.065Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.